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    Summary
    EudraCT Number:2015-002058-11
    Sponsor's Protocol Code Number:CRO-2015-17
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002058-11
    A.3Full title of the trial
    RIMMEL STUDY: Radiotherapy and ipilimumab in melanoma. Phase II clinical trial in patients with metastatic melanoma
    STUDIO RIMMEL: Radioterapia e Ipilimumab nel MELanoma. Sperimentazione clinica di Fase II in pazienti con melanoma metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RIMMEL STUDY: Radiotherapy and ipilimumab in melanoma. Phase II clinical trial in patients with metastatic melanoma
    STUDIO RIMMEL: Radioterapia e Ipilimumab nel MELanoma. Sperimentazione clinica di Fase II in pazienti con melanoma metastatico
    A.3.2Name or abbreviated title of the trial where available
    RIMMEL STUDY
    STUDIO RIMMEL
    A.4.1Sponsor's protocol code numberCRO-2015-17
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCENTRO DI RIFERIMENTO ONCOLOGICO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentro Riferimento Oncologico
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro di Riferimento Oncologico IRCCS
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressVia F. Gallini 2
    B.5.3.2Town/ cityAviano (PN)
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number+390434659066
    B.5.5Fax number+390434659453
    B.5.6E-mailgtabaro@cro.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name YERVOY - 5 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 10 ML 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameipilimumab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNipilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeCRO -2015-17
    D.3.9.3Other descriptive nameipilimumab
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic melanoma
    melanoma metastatico
    E.1.1.1Medical condition in easily understood language
    metastatic melanoma
    melanoma metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the therapeutic activity (disease control in the course of time) during stereotactic body radiotherapy (SBRT) in patients with metastatic melanoma treated with first line Ipilumumab.
    Valutare l¿attivit¿ terapeutica (controllo della malattia nel tempo) della radioterapia stereotassica corporea (SBRT) nei pazienti affetti da melanoma metastatico sottoposti a trattamento di prima linea con Ipilumumab.
    E.2.2Secondary objectives of the trial
    To evaluate the therapeutic activity (lesion volume reduction) during the treatment with SBRT - "target lesions" - and other metastatic lesions not irradiated, the toxicity profile and the immunogenic activity of SBRT in patients with metastatic melanoma treated with Ipilumumab.
    Valutare l¿attivit¿ terapeutica (riduzione volumetrica delle lesioni sottoposte a SBRT ¿ ¿lesioni target¿ e delle altre lesioni a distanza non irradiate), il profilo di tossicit¿ e l¿attivit¿ immunogenica della radioterapia stereotassica corporea (SBRT) nei pazienti affetti da melanoma metastatico sottoposti a trattamento con Ipilimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Diagnosis of stage III-IV melanoma with indication to treatment with ipilimumab
    - Two or more metastatic lesions measurable criteria mWHO immunocorrelati (24)
    - Age> = 18
    - Life expectancy >= 4 months
    - ECOG 0-1
    - Adequate bone marrow function (WBC> 3.0 x 10 ^ 3 / pL; N> 1.5 x 10 ^ 3 / pL; PLT> 100 x10 ^ 3 / pL; Hb> 10 g / dL)
    - Adequate renal function (serum creatinine <= 1.5xUNL).
    - Adequate hepatic function (Total bilirubin <= 1.5xUNL; AST-SGOT, SGPT ALT-<= 2.5xUNL; FAL and ¿GT <= 5xUNL)
    - Written informed consent
    - Geographical accessibility
    - Diagnosi di melanoma in stadio III o IV con indicazione a trattamento con Ipilimumab
    - Due o più lesioni metastatiche misurabili secondo criteri mWHO immunocorrelati (24)
    - Età >= 18
    - Aspettativa di vita di almeno 4 mesi
    • ECOG 0-1
    • Adeguata funzionalità midollare (WBC > 3.0 x10^3/µL; N > 1.5 x10^3/µL; PLT > 100 x10^3/µL; Hb > 10 g/dL)
    - Adeguata funzionalità renale (Creatinina serica <= 1.5xUNL).
    - Adeguata funzionalità epatica (Bilirubina totale<= 1.5xUNL; AST-SGOT, ALT-SGPT <= 2.5xUNL; FAL e ¿GT <= 5xUNL)
    • Consenso informato scritto
    • Accessibilità geografica
    E.4Principal exclusion criteria
    - Untreated brain metastases or progression phase
    - Impediments logistics of the patient to participate in the study, and to afferire with regularity at the center participant (as regards the treatment part and the subsequent part of follow-up).
    - Presence of clinically significant cardiovascular disease. For example: Cerebrovascular accident (within 1 year), acute coronary syndrome (within 1 year), unstable angina, symptomatic heart failure (New York Heart Association - NYHA) grade II or higher, cardiac arrhythmia applicant drug therapy.
    -There is no known contraindications for each of the drugs used in the study (known hypersensitivity to the active substance, to lactose or to any of the excipients, hereditary fructose intolerance, peripheral sensory neuropathy with functional impairment, chronic inflammatory bowel disease and / or bowel obstruction , diverticulitis, patients in a state of malnutrition, patients with serious infections)
    - Diagnosis of other malignancy with disease-free interval <5yrs from enrollment, with the exception of the squamous cell or basal and squamous skin, and cancer of the cervix in situ, breast cancer or bladder cancer.
    - Presence of autoimmune diseases (excluding vitiligo)
    - Previous treatment with antibody anti-CTLA-4
    - Administration of vaccines up to 1 month before or after administration of ipilimumab
    - Concomitant use of immunosuppressive drugs or use of systemic corticosteroids
    - Presence of malabsorption, weight loss, active, diarrhea or grade = 2 seconds to NCI Common Toxicity Criteria vs. 4.03.
    - Presence of residual toxicity from prior treatments symptomatic grade = 1 second NCI Common Toxicity Criteria vs. 4.03.
    - Women who are pregnant or lactating.
    - Women of childbearing age with positive pregnancy test or who refuse the test run (not considered fertile women with a history of amenorrhea for at least 12 months).
    - Men and women of childbearing potential and sexually active who refuse or are unable to use contraceptive methods. They are accepted as methods of birth control during the duration of the study complete abstention or the use of two methods of birth control proven to be effective, one barrier (eg. Condoms) and one chemical (eg. "Pill")
    - Metastasi cerebrali non trattate o in fase di progressione
    - Impedimenti logistici del paziente a partecipare allo studio, e ad afferire con regolarità al centro partecipante (per quanto riguarda la parte di trattamento e la successiva parte di follow-up).
    - Presenza di malattia cardiovascolare clinicamente significativa. Ad esempio: Accidente cerebrovascolare (entro 1 anno), sindrome coronarica acuta (entro 1 anno), angina instabile, scompenso cardiaco sintomatico (secondo New York Heart Association – NYHA) di grado II o superiore, aritmia cardiaca richiedente terapia farmacologica.
    - Presenza di controindicazioni note per ciascuno dei farmaci utilizzati nello studio (ipersensibilità nota al principio attivo, al lattosio o a uno qualsiasi degli eccipienti, intolleranza ereditaria al fruttosio, neuropatia periferica sensitiva con compromissione funzionale, malattia infiammatoria cronica dell’intestino e/o occlusione intestinale, diverticolite, pazienti in stato di denutrizione, pazienti con serie infezioni)
    - Diagnosi di altra neoplasia maligna con un intervallo libero da malattia <5 anni dall'arruolamento, con eccezione per il carcinoma a cellule o basali e squamoso della cute, e per il carcinoma della cervice in situ, della mammella, o della vescica.
    - Presenza di malattie autoimmuni (esclusa la vitiligine)
    - precedente trattamento con anticorpi anti-CTLA-4
    - Somministrazione di vaccini fino a 1 mese prima o dopo la prima somministrazione di Ipilimumab
    - Uso concomitante di farmaci immunosoppresori o uso di corticosteroidi per via sistemica
    - Presenza di sindrome da malassorbimento, calo ponderale attivo, o diarrea di grado = a 2 secondo NCI Common Toxicity Criteria vs. 4.03.
    • Presenza di tossicità residua da precedenti trattamenti sintomatica di grado = 1 secondo NCI Common Toxicity Criteria vs. 4.03.
    - Donne in gravidanza o in allattamento.
    - Donne in età fertile con test di gravidanza positivo o che rifiutano l’esecuzione del test (non sono considerate fertili donne con in anamnesi amenorrea da almeno 12 mesi).
    - Donne e uomini potenzialmente fertili e sessualmente attivi che rifiutano o che sono impossibilitati all’utilizzo di metodi contraccettivi. Sono accettati come metodi anticoncezionali durante tutta la durata dello studio l’astensione completa oppure l’utilizzo di 2 metodi anticoncezionali di dimostrata efficacia, uno di barriera (es. condom) e uno chimico (es. “pillola”).
    E.5 End points
    E.5.1Primary end point(s)
    progression free survival
    sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    E.5.2Secondary end point(s)
    terapeutic activity; acute and long term toxicity; immunogenic of SBRT in combination with ipilimumab; overall survival; Quality assessment of life questionnaire EORTC QLQ-C30 (version 3.0)
    attivit¿ terapeutica; Tossicit¿ acuta e tardiva; attivit¿ immunogenica della SBRT in associazione a Ipilimumab; Sopravvivenza globale; Valutazione della qualit¿ della vita con questionario EORTC QLQ-C30 (versione 3.0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable; not applicable; not applicable; not applicable; not applicable
    non applicabile; non applicabile ; non applicabile; non applicabile; non applicabile
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    not applicable
    non applicabile
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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